MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER; PROSTHESIS, SHOULDER

Catalog Number 00434903611

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pro code: phx.Concomitant medical products: poly liner plus 3 mm offset 36 mm diameter, cat# 00434903603, lot# 62501858.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01999.

Event Description

It was reported that a patient underwent a right total shoulder arthroplasty.Subsequently, the patient was revised approximately 6 years later for pain and possible instability (subluxation not full dislocation).Poly liner was removed and 36 glenosphere was exchanged for 40 glenoshpere and thicker poly liner implanted.Removed poly liner showed some inferior/posterior wear.During the surgical procedure, the surgeon mentioned that there may be signs of notching of the scapular neck.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap film of the right shoulder demonstrates a reverse total shoulder arthroplasty in place.There does appear to be notching of the inferior scapular neck.Normal position of the glenosphere.Humeral component is intact with no radiolucency.No acute fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: GLENOSPHERE 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10119260
• MDR Text Key: 194114876
• Report Number: 0001822565-2020-01998
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 00434903611
• Device Lot Number: 62552658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 54